The SEC has asked the Hyderabad-based drugmaker to submit the fact sheet for the vaccine along with details on stability of Sputnik V as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius
A subject expert committee of India’s drug regulator has deferred its decision on recommending the Sputnik V vaccine for emergency licensure, instead asking its applicant Dr Reddy’s Laboratories for additional data for the vaccine, two people aware of the development said.
The SEC has asked the Hyderabad-based drugmaker to submit the fact sheet for the vaccine along with details on stability of Sputnik V as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius, one of the persons cited above said.
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Premium While the liquid form of the vaccine requires storage temperature of -18 degree Celsius, the lyophilized form can be stored at 2 to 8 degree Celsius.
Dr Reddy’s is in a pact with Russian Direct Investment Fund, the co-developer of the vaccine, wherein the Indian firm will conduct clinical trials and also distribute the vaccine in the country after it secures an authorisation.
The Indian drugmaker had applied for the emergency use authorisation with the regulator in February but was asked to return after it completed its phase 2 and 3 bridging study.
Sputnik V, which was co-developed by RDIF and Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, has one of the highest efficacies for vaccines that will be available in India with an interim efficacy of 91.6%.
Apart from Dr Reddy’s supply and clinical trial pact, RDIF has also signed manufacturing pacts with four Indian companies for a total of around 750 million doses. The companies are Hetero Biopharma, Gland Pharma, Stelis Biopharma and Virchow Biotech. Apart from the four, the Russian sovereign fund is also in talks with Delhi-based vaccine maker Panacea Biotec for manufacturing the vaccine.
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